BEUDAMED
    FDA Recall Terminated

    Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and 43589-01; the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick; Medline Industries, Inc., Mundelein, IL 60060;

    Recall: Z-0554-05 · Initiated March 4, 2005

    Recall

    Recall Number
    Z-0554-05
    Event Number
    31315
    Firm
    Medline Industries, Inc.
    FEI Number
    3000717925
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2005
    Posted
    March 11, 2005
    Terminated
    May 25, 2006
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and 43589-01; the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick; Medline Industries, Inc., Mundelein, IL 60060;

    Reason

    There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.

    Action

    Field Correction letters dated 3/4/05 were sent to thedirect account hospitals on the same date to the attention of the manager of surgery, informing them of the potential indadequate side seal of the Tyvek breather pouches in the packs which may cause a compromise in the sterility of the product. The accounts were provided a list of the affected pack sent to the account and were requested to inspect any stocks of the affected product in stock, using the enclosed diagrams as an aid in the inspection for the defective side seals. Any defective product found should be returned to Medline. Any questions were directed to Lara Simmons, QA/RA Director at 1-800-879-2781, ext. 6072.

    Distribution

    Nationwide

    Quantity

    31,497 cases